This document is an order issued by the Ministry of Chemicals and Fertilizers, Department of Pharmaceuticals, Government of India, on March 22, 2016. It concerns amendments to the Drugs Prices Control Order (DPCO) of 2013, specifically addressing the pricing of injections, inhalations, and other medicines where dosage form or strength are not specified in Schedule I of the DPCO, 2013.
The order grants the government the authority to fix and notify separate ceiling prices or retail prices for such formulations, considering therapeutic rationale, packaging, pack size, dosage compliance, content form (liquid, gaseous, etc.), and unit dosage, conforming to Indian Pharmacopeia or other standards specified in the Drugs and Cosmetics Act, 1940.
Furthermore, the order mandates the formation of a Committee of Experts within fifteen days of the order's issuance. This committee will be responsible for recommending the fixing of separate ceiling prices for scheduled formulations or retail prices for new drugs based on the parameters outlined in the order.
The order number is S.O. 1192(E), and the F. No. is 31011/22015-PIII. The Joint Secretary, Sudhansh Pant, is the signing authority.
Key Entities Referenced
Essential Commodities Act, 1955: A law that empowers the Central Government to control the production, supply, and distribution of essential commodities.
Drugs Prices Control Order, 2013: An order issued by the Ministry of Chemicals and Fertilizers, Department of Pharmaceuticals, to regulate the prices of drugs.
Ministry of Chemicals and Fertilizers: The government ministry responsible for the chemical and fertilizer industries.
Department of Pharmaceuticals: A department within the Ministry of Chemicals and Fertilizers focused on the pharmaceutical sector.
New Delhi: The capital city of India, where the order was issued.
Gazette of India: The official government publication where the order was published.
ScheduleI of the Drugs Prices Control Order, 2013: Refers to a specific schedule within the Drugs Prices Control Order, 2013, which likely lists drugs or formulations.
Drugs and Cosmetics Act, 1940: An act regulating the import, manufacture, distribution and sale of drugs and cosmetics.
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[फा.सं. 31011/2/2015-पीआई-2]
सुधांश पंत, संयुD त सिच व,
MINISTRY OF CHEMICALS AND FERTILIZERS
(Department of Pharmaceuticals)
ORDER
New Delhi, the 22nd March 2016
S.O. 1192(E).—In exercise of the powers conferred by Section 3 of the Essential Commodities Act, 1955
(10 of 1955), the Central Government hereby makes the following amendments in the Drugs (Prices Control) Order,
2013 issued by the Ministry of Chemicals and Fertilizers, Department of Pharmaceuticals published in the Gazette of
India, Extraordinary, Part II, Section 3, Sub-section (ii), vide number S.O. 1221(E), dated 15th May, 2013, namely :-
In the Drugs (Prices Control) Order, 2013 in Paragraph-11, after sub-paragraph (2), the following
sub-paragraphs shall be inserted, namely :-
“(3) Notwithstanding anything contained in sub-paragraphs (1) and (2), in the case of injections or inhalation or
any other medicine for which dosage form or strength or both are not specified in the Schedule-I of the
Drugs (Prices Control) Order, 2013, the Government may fix and notify separate ceiling price or retail price
for such formulations with specific therapeutic rationale, considering the type of packaging or pack size or
dosage compliance or content in the pack namely liquid, gaseous or any other form, in the unit dosage as
the case may be, conforming to Indian Pharmacopeia or other standards as specified in the Drugs and
Cosmetics Act, 1940 (23 of 1940) and the rules made thereunder for the same formulation.
(4) The Government shall form a Committee of Experts, as it may deem fit, within a period of fifteen days
from the date of issue of this order, to recommend fixing of separate ceiling price of scheduled formulations
or retail price of a new drug as per the above parameters”.
[F. No. 31011/2/2015-PI-II]
SUDHANSH PANT, Jt. Secy.
Uploaded by Dte. of Printing at Government of India Press, Ring Road, Mayapuri, New Delhi-110064
and Published by the Controller of Publications, Delhi-110054.